Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients

February 3, 2022 updated by: Na Jiang, Shanghai Jiao Tong University School of Medicine
Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESRD patients who start the PD at the first time

Description

Inclusion Criteria:

  • ESRD patients
  • The first time of peritoneal dialysis

Exclusion Criteria:

  • Age <18 years at start of PD
  • Transfer or follow-up loss
  • Previous transplantation or HD history
  • Incomplete clinical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
A
defined as patients survived on PD for more than 10 years
B
defined as patients survived on PD for 5-10 years
C
defined as patients survived on PD within 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baseline clinical characteristics before PD
Time Frame: within one month before the start of PD
clinical characteristics about age,sex,comorbidities before PD,laboratory data would be aggregated from the existing record to find out the differences between the long-term PD patients and the others that may affect their clinical outcome.
within one month before the start of PD

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the factors that may lead to the termination of PD
Time Frame: up to 20 years
Some patients may end the PD early ,some late due to many reasons.To find out the factors that may influence survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment, the investigators collect and record the reasons for termination of PD to analyze.
up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Wei Fang, MD, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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